D-lactate test in spinal fluid for suspected ventriculostomy-related meningitis

Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis : a Pilot Study

This will test whether measuring D-lactate in cerebrospinal fluid helps diagnose meningitis in adults with an external ventriculostomy who are suspected of having a hospital-acquired infection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 185 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Toulouse (Academic / other)
• Locations: 1 site (Toulouse)
• Trial ID: NCT06482463 on ClinicalTrials.gov

What this trial studies

This single-center study in the neurosurgical ICU at Toulouse University Hospital collects an extra cerebrospinal fluid (CSF) sample when clinicians perform routine sampling for suspected ventriculostomy-related nosocomial meningitis. Samples are frozen at -80°C and will undergo serial assays for D‑lactate, procalcitonin (PCT), and pro-inflammatory cytokines (IL-1, IL-6, IL-8, TNFα). If the initial CSF does not meet diagnostic criteria, a second sample is taken 48–96 hours later; final clinical classification of meningitis versus no meningitis is made retrospectively by two neurosurgical intensivists using the medical record. Participants are followed through an end-of-participation visit at four weeks.

Who should consider this trial

Good fit: Adults (age ≥18) at Toulouse University Hospital who have an external ventriculostomy and are currently suspected of having ventriculostomy-related nosocomial meningitis are eligible.

Not a fit: Patients with community-acquired meningitis, recent meningitis within the past month, severe renal failure or on peritoneal dialysis, short bowel syndrome, or those already diagnosed elsewhere are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the D‑lactate test could provide a faster and more specific CSF marker to distinguish ventriculostomy-related meningitis from noninfectious inflammation, helping guide timely antibiotic decisions.

How similar studies have performed: CSF procalcitonin and cytokine measurements have some supporting data for diagnosing nosocomial meningitis, but using D‑lactate in CSF for ventriculostomy-related meningitis is relatively novel with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

* Age ⩾ 18 years.
* Patient with an external ventriculostomy implanted at the Toulouse University Hospital.
* Patient suspected of nosocomial meningitis due to a febrile syndrome (in the absence of any other identified infectious site), headache, nausea, lethargy, change in neurological status, meningeal syndrome, epileptic event and cutaneous or subcutaneous inflammation at the ventriculostomy site of insertion.
* Patient having expressed oral consent, after free and informed information.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Diagnosis of community meningitis.
* Proven or suspected meningitis and/or ventriculitis during the previous month.
* Diagnosis of nosocomial meningitis made in another medical centre prior to admission.
* Short bowel syndrome.
* Acute mesenteric ischaemia.
* End-stage renal failure (GFR \< 15 ml/min/m2).
* Peritoneal dialysis.
* Patient participating in another research protocol with an exclusion period still in progress.
* Pregnant or breastfeeding woman.
* Patient under guardianship or trusteeship, persons placed under the protection of justice

Where this trial is running

Toulouse

• Toulouse Hospital — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Lucie LELIEVRE, Md

Conditions Nosocomial Infection; External ventriculostomy; Nosocomial meningitis; Bacterial meningitis